Efficacy of PENS of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix Patients

NCT05742711 | Completed DMC

• 1 other identifier: CS015
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Pain relief following laparotomy surgery requires a variety of techniques including invasive ones like epidural or nerve blocks along with different classes of drugs, out of which opioids are most predominant. Each of these drugs have with their own set of advantages and also side effects. An ideal common system of analgesia is not possible due to patient variability. And no drug is devoid of side effects. Hence the aim is to ensure effective analgesia using drugs or techniques which are minimally invasive with negligible side effects.

Conditions

Cancer of Endometrium; Cancer of Cervix

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  The primary goal is to evaluate the efficacy of PENS treatment in the change in postoperative pain after cancer surgery compared to the control group. The pain is measured using the numerical rating scale (NRS). Pain Score will be measured on a scale (0 = no pain;10 = worst imaginable pain; lower scores indicate better outcome)

  0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours. Outcomes will be reported as an average over each individual postoperative day and as an average over 5 days independently for rest.

Secondary Outcomes (7)

• Overall Postoperative analgesia and opioid requirement

  0 - 4 days, duration and dose of all prescriptions are recorded.

• Patient Ambulation

  1 - 4 days; 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.

• Record of Participant Bowel Movement Patterns

  0 - 4 days; Whenever the patient experiences the bowel movement.

• Richmond Agitation Sedation Scale (RASS)

  0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.

• Patient Discomfort

  Time Frame: 0 - 4 days; Whenever the patient experiences the discomfort.

Study Arms (2)

Treatment Group

EXPERIMENTAL

The group who have received PENS treatment using PrimaryRelief in addition to Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS\>4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain.

Device: Primary Relief

Control Group

SHAM COMPARATOR

The group who have received a sham device along with Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS\>4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain.

Device: Primary Relief - Sham Device

Interventions

Primary Relief DEVICE

Continuous neurostimulation with a set of pre-assigned stimulation parameters.

Also known as: Percutaneous Electrical Nerve Stimulator (PENS)

Treatment Group

Primary Relief - Sham Device DEVICE

Standard treatment with the application of sham device shall be followed with additional analgesics available if necessary.

Also known as: Standard Treatment for Postoperative Pain

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 yrs
• Diagnosed with CA-endometrium OR CA -cervix of stage I/II and post RT CA cervix patients coming for hysterectomy
• Elective surgery
• Informed consent obtained
• ASA (American Society of Anaesthesiology) physical status 1-3

You may not qualify if:

• Patient refusal
• Emergency surgery, Laparoscopic and robotic procedures
• Unplanned postoperative ventilation
• Allergy/sensitivity to adhesive
• Active skin infection/lesion in the ear region
• H/O of seizure or cerebral disease
• H/O chronic pain and prolonged analgesic usage
• H/O opioid dependence
• H/O anxiety or psychiatric illness requiring treatment
• Pre-existing implantable/ electronic on demand device
• Patients who might require MRI in the study period
• Patients with transmissible diseases
• Patients with coagulopathies
• Absolute or relative contraindication to drugs used in the study

Sponsors & Collaborators

• DyAnsys, Inc.: lead

Study Sites (1)

Cancer Institute,(Wia)

Chennai, Tamil Nadu, 600020, India

Location

Related Publications (2)

• Arponrat P, Pongrojpaw D, Tanprasertkul C, Suwannarurk K, Bhamarapravatana K. Postoperative Pain Relief in Major Gynaecological Surgery by Perioperative Parecoxib Administration: Thammasat University Hospital Study. J Med Assoc Thai. 2015 Jul;98(7):636-42.

  PMID: 26267984 RESULT

• Pogatzki-Zahn E, Kutschar P, Nestler N, Osterbrink J. A Prospective Multicentre Study to Improve Postoperative Pain: Identification of Potentialities and Problems. PLoS One. 2015 Nov 24;10(11):e0143508. doi: 10.1371/journal.pone.0143508. eCollection 2015.

  PMID: 26600464 RESULT

Related Links

• Pattern of use of analgesics in post-operative pain management in adults undergoing laparotomy surgery: a prospective observational study

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Study Officials

• Dr. Sahithya Sriman, MBBS, MD

  Cancer Institue, WIA,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 24, 2023
• Study Start: May 16, 2023
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)